Trial Outcomes & Findings for Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma (NCT NCT00071981)
NCT ID: NCT00071981
Last Updated: 2023-06-28
Results Overview
Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8
Results posted on
2023-06-28
Participant Flow
This study was activated on March 21, 2005, accrued its first patient on May 9, 2005, and terminated on January 12, 2009 with the final accrual of 175 patients.22 ECOG institutions participated in the study.
This study involved a pre-registration before randomization. For patients with locally-typed HLA status, randomization immediately followed pre-registration. For central evaluation of HLA status, samples were submitted after pre-registration, and results of the evaluation must have been received from the central laboratory prior to randomization
Participant milestones
| Measure |
Arm I (12MP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
43
|
37
|
48
|
|
Overall Study
Eligible
|
43
|
36
|
33
|
42
|
|
Overall Study
Treated
|
45
|
38
|
36
|
48
|
|
Overall Study
Eligible and Treated
|
41
|
33
|
32
|
42
|
|
Overall Study
Have CTL Response Data
|
40
|
30
|
29
|
41
|
|
Overall Study
Have Helper T Cell Response Data
|
37
|
27
|
25
|
39
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
46
|
41
|
37
|
45
|
Reasons for withdrawal
| Measure |
Arm I (12MP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
37
|
29
|
30
|
43
|
|
Overall Study
Adverse Event
|
4
|
4
|
3
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
|
Overall Study
No protocol therapy
|
2
|
5
|
1
|
0
|
|
Overall Study
others (not specified in the study)
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Arm I (12MP)
n=41 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=33 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=32 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=42 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
69 years
n=7 Participants
|
66 years
n=5 Participants
|
64 years
n=4 Participants
|
66 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
33 participants
n=7 Participants
|
32 participants
n=5 Participants
|
42 participants
n=4 Participants
|
148 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8Population: 140 eligible and treated patients who had CTL response data were included in the analysis
Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.
Outcome measures
| Measure |
Arm I (12MP)
n=40 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=30 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=29 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=41 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Cytotoxic T-cell Lymphocytes (CTL) Response Rate
|
43 percentage of participants
Interval 27.0 to 59.0
|
47 percentage of participants
Interval 28.0 to 66.0
|
28 percentage of participants
Interval 13.0 to 47.0
|
5 percentage of participants
Interval 0.6 to 16.5
|
SECONDARY outcome
Timeframe: Immune response was assessed at pre-registration, in weeks 1,3,5,7,8Population: 128 eligible and treated patients who had data about helper T cell response were included in the analysis
Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.
Outcome measures
| Measure |
Arm I (12MP)
n=37 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=27 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=25 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=39 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Helper T-cells Response to 6MHP
|
3 percentage of participants
Interval 0.0 to 14.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
40 percentage of participants
Interval 21.0 to 61.0
|
41 percentage of participants
Interval 26.0 to 58.0
|
SECONDARY outcome
Timeframe: Immune response was assessed at pre-registration, in weeks 1,3,5,7,8Population: 128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis
Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.
Outcome measures
| Measure |
Arm I (12MP)
n=37 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=27 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=25 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=39 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Helper T Cell Response to Tetanus
|
11 percentage of participants
Interval 3.0 to 25.0
|
59 percentage of participants
Interval 39.0 to 79.0
|
4 percentage of participants
Interval 0.0 to 20.0
|
0 percentage of participants
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccinationPopulation: 148 eligible and treated patients were included in the analysis
Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.
Outcome measures
| Measure |
Arm I (12MP)
n=41 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=33 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=32 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=42 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Objective Response Rate
|
2.4 percentage of participants
Interval 0.06 to 12.8
|
3.0 percentage of participants
Interval 0.08 to 15.8
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
7.1 percentage of participants
Interval 1.5 to 19.5
|
SECONDARY outcome
Timeframe: assessed every 3 month within 2 years and every 6 months betwen 2 and 5 yearsPopulation: 148 eligible and treated patients were included in the analysis
OS was defined as the time from registration to death from any cause.
Outcome measures
| Measure |
Arm I (12MP)
n=41 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=33 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=32 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=42 Participants
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Median Overall Survival (OS)
|
14.9 months
Interval 10.1 to 18.6
|
10.2 months
Interval 6.7 to 12.2
|
12.4 months
Interval 4.8 to 16.8
|
11.1 months
Interval 8.8 to 14.2
|
Adverse Events
Arm I (12MP)
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Arm II (12MP/Tet)
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm III (12MP/6MHP)
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm IV (6MHP)
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (12MP)
n=45 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=38 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=36 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=48 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Alanine aminotransferase (ALT, SGPT)
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Aspartate aminotransferase (AST, SGOT)
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Metabolic/Laboratory-other
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Nervous system disorders
Central nervous system (CNS) cerebrovascular ischemia
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Nervous system disorders
Head/headache
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Leukopenia (Leukocytes decreased)
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Lymphopenia
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Neutropenia (Neutrophils decreased)
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Cardiac troponin I (cTnI)
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Fatigue
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
10.5%
4/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.9%
5/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Injection site reaction
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
Other adverse events
| Measure |
Arm I (12MP)
n=45 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
|
Arm II (12MP/Tet)
n=38 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection
|
Arm III (12MP/6MHP)
n=36 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
Arm IV (6MHP)
n=48 participants at risk
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection
|
|---|---|---|---|---|
|
Investigations
Leukopenia (Leukocytes decreased)
|
6.7%
3/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.2%
5/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Lymphopenia
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
21.1%
8/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
16.7%
6/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
8.3%
4/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Neutropenia (Neutrophils decreased)
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Thrombocytopenia (Platelets decreased)
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Alanine aminotransferase increased (ALT, SGPT)
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Fatigue
|
20.0%
9/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
28.9%
11/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
27.8%
10/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
14.6%
7/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Fever w/o neutropenia
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
10.5%
4/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Rigors/chills
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.2%
5/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
11.1%
4/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
General disorders
Injection site reaction
|
62.2%
28/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
52.6%
20/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
50.0%
18/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
37.5%
18/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.9%
4/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.9%
5/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
8.3%
3/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
6.7%
3/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
6.2%
3/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
15.8%
6/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
8.3%
3/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Alkaline phosphatase increased
|
8.9%
4/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
8.3%
4/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Aspartate aminotransferase increased (AST, SGOT)
|
6.7%
3/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.2%
5/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Creatinine increased
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
7.9%
3/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
10.4%
5/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Investigations
Metabolic/Laboratory-other
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.9%
5/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
6.2%
3/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.3%
2/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
0.00%
0/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Nervous system disorders
Head/headache
|
11.1%
5/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
13.2%
5/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
8.3%
3/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
4.2%
2/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
4.4%
2/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.8%
1/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
6.2%
3/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
13.3%
6/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.6%
1/38 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
5.6%
2/36 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
2.1%
1/48 • Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility.
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place